A former Raytheon laser engineer, Rudko founded PLC Systems, Inc. and developed the patented Heart Laser(TM) It's used for transmyocardial revascularization, a possible future alternative to bypass surgery and angioplasty now being evaluated by the FDA as part of its pre-market approval process.
Design News: Please summarize the FDA approval process for medical devices.
Rudko: You and your facility both have to be cleared by the FDA. For low-risk devices, they're only concerned with good manufacturing practices. Devices like ours require a clinical trial. In general, the FDA clearance process takes about 27 months. We started designing the laser in 1988 and got approval for first clinical trials in 1990. Our phase 2 trials began in 1992, and now we are requesting pre-market approval to use the Heart Laser to be used on patients with no other alternative.
Q: You already sell the Heart Laser outside the U.S. How are approval procedures different overseas from what they are in the U.S.?
A:Outside the U.S., all they care about is that you prove it's a safe device. They're not worried about whether it's effective. They leave that to the doctors to decide. The FDA, on the other hand, determines whether the device is effective and what it can be used for. Personally, I think the FDA should leave use of the device up to the doctor. The FDA is also concerned about "off-label" use. Once they approve a device, they can't stop a doctor from using it for something else. So, the FDA makes sure manufacturers' literature doesn't promote the device for any indications other than what it's been approved for.
Q: What can prevent a doctor from using a new device for a non-approved procedure?
A: Reimbursement. They may not get paid if they use it for a non-approved indication. In fact, financial approval becomes another part of the overall approval process. We have to go to the Health Care Fin- ance Agency and get them to decide the procedure is reimbursable and get a reimbursement code. Private insurers and HMOs are another story. They'll follow the Health Care Finance Agency, but they can also do it on their own. Several insurers will already pay for TMR even though it's investigational because they think it's cost-effective. The government's criteria for reimbursement comes down to clinical effectiveness. But even if a device is effective, if it's much more costly, it might not be approved for reimbursement.
Q: What are the benefits to manufacturers of the process?
A: The benefits for manufacturers are that the FDA is so tough that anywhere in the world will accept you with no questions if your device is FDA-approved. Also, competitors have to go through the same process. The FDA can't use anything they learned from one manufacturer to help another. So, effectively, the first manufacturer to win approval has the market to itself for about three years.
Q: What are the impediments?
A: The cost. If you have to do years of clinical trials and then not market the product for two more years, that's expensive. There's no reimbursement, even for the hospital stay. The FDA even has control over your exports if it's not approved. We have to get a letter from a country that wants to use the device saying they understand it's investigational only in the U.S. and they have no objection to importing it. Lately, the turnaround time for FDA approval of those letters has been only two or three weeks. But it used to be 12-15 weeks.
Q: What are the specific concerns foremost in the minds of your design engineers as they try to produce a product that meets FDA approval?
A: They have to be concerned with the operating room environment. Reliability is the key. If something goes wrong, the system must shut down. They don't have to worry about temperature or humidity in U.S. operating rooms, but do have to for some overseas. But, they have to keep in mind that they can't depend on fans blowing things around as cooling devices. And, they have to remember that the users, surgeons, may not be technical, so systems have to be easy to use.
Q: Please explain briefly how your Heart Laser works in Transmyocardial revascularization.
A: Transmyocardial revascularization is intended to be an alternative to bypass surgery and angioplasty. It's a cardiosurgical procedure that uses the Heart Laser and a sterile kit to "drill" 15 to 30 1-mm-diameter channels in the left ventricular chamber of a beating heart, giving oxygenated blood a direct conduit to oxygen-starved tissue. The laser is computer synchronized with the patient's heartbeat and triggered to fire between heartbeats, when the left ventricle is filled with blood. The blood is a backstop for the laser's energy, preventing it from damaging other heart tissue.
Q: What has been your specific role in developing the technology?
A: We pioneered the procedure, and developed the Heart Laser that makes it practical.